NCT07163819

Brief Summary

International travel disrupts gut health through dietary changes, microbial exposure, and stress, often causing gastrointestinal symptoms like traveler's diarrhea and sleep disturbances. These shifts may increase antibiotic resistance risks. Probiotics may help stabilize gut microbiota and improve well-being during travel. This randomized, double-blind, placebo-controlled trial investigated whether probiotic supplementation mitigates gut microbiota perturbations, gastrointestinal symptoms, and sleep issues in adults traveling abroad. The investigators also assessed changes in anxiety, well-being, gut immunity, microbial function, and antibiotic resistance genes.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2025

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 1, 2025

Last Update Submit

September 10, 2025

Conditions

Healthy Adults

Keywords

probioticinternational travel

Outcome Measures

Primary Outcomes (1)

  • Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing

    Differences in microbiota abundance in fecal sample of generally healthy adults upon administration o probiotic compared to placebo

    7 days

Secondary Outcomes (5)

  • Respiratory symptoms duration and frequency in generally healthy adults upon administration of probiotic as assessed using questionnaire

    7 days

  • Gastrointestinal symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire

    7 days

  • Allergy symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire

    7 days

  • Gastrointestinal metabolites in generally healthy adults upon administration of probiotic as assessed using LC-MS

    7 days

  • Quality of life in generally healthy adults upon administration of probiotic as assessed using questionnaire

    7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil

Other: Placebo

Probiotic

EXPERIMENTAL

Daily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)

Other: Probiotic

Interventions

ProbioticOTHER

Daily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)

Probiotic
PlaceboOTHER

Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy adults
  • Scheduled to undertake a short-term round trip (less than 7 days) to abroad
  • Able to complete study procedures
  • Willing to take intervention products

You may not qualify if:

  • Use of antibiotics, probiotics, hormones, immunosuppressants, biologics or JAK inhibitors within four weeks prior to study
  • Chronic or severe systemic diseases (including cardiovascular, hepatic, renal, malignant or psychiatric disorders)
  • Uncontrolled parasitic infections
  • Long-term use of corticosteroids, growth hormone, vitamin B12, lysine or inositol
  • Major surgery within one month
  • Allergy to probiotic components
  • Other conditions deemed inappropriate by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tsinghua University Science and Technology

Haidian, Beijing Municipality, 100080, China

RECRUITING

Universiti Sains Malaysia

George Town, Pulau Pinang, 11800, Malaysia

NOT YET RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ai Zhou, Ph.D.

    Tsinghua University Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Tze Liong, Ph.D.

CONTACT

6046532114mintze.liong@usm.my

Yuan Jie, M.Sc.

CONTACT

822137027899peanut.yuan@diprobio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 9, 2025

Study Start

July 31, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)MY(1)